BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772046 · Received November 2, 2007

    Report

    Report Number
    1823260-2007-09535
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 12, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 549916, EXPIRATION DATE 11/30/2008). REFERENCE MEDWATCH REPORT WITH (B)(4) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTS NEONATE PATIENT REPORTEDLY RECEIVED RESULT OF 39 MG/DL ON INFORM SYSTEM 1 AND 61 MG/DL ON INFORM SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, CUSTOMER DID NOT RETURN TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549916

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA